Efficacy Study of Two Silicon-based Products to Treat Scars (Kelofin)

Ache Laboratorios Farmaceuticos

Status: Withdrawn

Conditions: Scars

Treatments: Other: Silicon-based gel; Other: Silicon-based aerosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02584010

All-M-42361-01-08-14

Details and patient eligibility

About

This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars.

Full description

Improve the final aspect of scars, have been a challenge for medicine. Silicon based products have been used in various ways to prevent hypertrophic scars and keloids since 1980. A great percentage of studies shows that silicon-based products improves the aspect of scars in different pathologies. The main objective of this trial is to evaluate the efficacy, using the Vancouver scale, of two silicon-based products (Kelofin gel and Kelofin aerosol) after 180 days.

300 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of thre treatment groups( Kelofin Gel, Kelofin Aerosol and no treatment) of the study.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fitzpatrick skin phototype I, II, III or IV
• Participant that has a recent surgical scar on remodeling phase (14 ± 7 days after surgery) from the following: breast plastic with inframammary incision (fold beneath the breast) or abdominoplasty, cesarean section, hysterectomy (removal of the uterus), oophorectomy (removal of ovaries), oophoroplasty (removal of nodules, cysts, etc. of the ovaries), salpingectomy (removal of the fallopian tubes), tubal ligation, exploratory laparotomy and ectopic pregnancy (pregnancy outside the uterus) (Pfannenstiel access road - transverse incision , below the navel and approximately one finger above the symphysis pubis).

Exclusion criteria

• Skin Pathology in the product application area;
• Diabetes;
• Immune impairment;
• Use of systemic corticosteroids or immunosuppressants;
• Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
• Background reaction to silicon-based products;
• Other illnesses or medications that may interfere directly in the study or endanger the health of the participant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Kelofin Aerosol

Experimental group

Description:

Silicon-based Aerosol that will be applied over the postoperative scar two times a day

Treatment:

Other: Silicon-based aerosol

Kelofin Gel

Experimental group

Description:

Silicon-based Gel that will be applied over the postoperative scar two times a day

Treatment:

Other: Silicon-based gel

Control

No Intervention group

Description:

This group will not receive any intervention as a control group.